Implanting method

ABSTRACT

A method for implanting artificial devices in the bodies of living creatures such as human beings. The device is initially embedded in tissue of the living creature where the device is permitted to remain until ingrowth of tissue into intimate contact with the exterior surface of the device is completed. Then the device is removed while retaining thereon a layer of the tissue which has grown into contact with the device, and the device with this layer of tissue thereon is then implanted in the body at the location where the device is to be used in the body with tissue at this latter part of the body engaging the tissue which has previously grown onto the device, so that the possibility of rejection of the device is reduced.

United States Patent 1191 Bucalo [11] 3,826,241 1451 July 30,1974

[ IMPLANTING METHOD Primary ExaminerRichard A. Gaudet [7,5] Lows fHolbrook Assistant Examiner-Ronald L. Frinks Asslgneei Investors InVentures, n New Attorney, Agent, or Firm-Steinberg & Blake York, NY.[22] Filed: Oct. 16, 1972 [57] ABSTRACT [21] App]. No.2 298,024 A methodfor implanting artificial devices in the bodies of living creatures suchas human beings. The device is initially embedded in tissue of theliving crea- [52] US. Cl. 128/1 R, 3/1, 128/92 C, tut-e where the deviceis permitted to remain um 128/334 128/419 32/10 A growth of tissue intointimate contact with the exterior [51] lltt. C1. A6" 1/24, A6lb 19/00Surface of the device is completed Then the device is [58] Flew Search-mBIG 3; 128/1 334R removed while retaining thereon a layer of the tissue128/92 92 419 P; 32/10 A which has grown into contact with the device,and the 1 device with this layer of tissue thereon is then im- [56]References a planted in the body at the location where the device isUNITED STATES PATENTS to be. used in the body with tissue at this latterpart of 3,514,791 6/1970 the body engaging the tissue which haspreviously 3,546,711 12/1970 grown onto the device, so that thepossibility of rejec- 3,699,957 10/1972 Robinson 128/] R tion of thedevice is reduced. 3,704,704 l2/l972 Gonzales l28/l R 3.710.777 1/1973Sparks l28/l R 9 Claims, 4 Drawing Figures R 32 i LU Pmmwwwm 3.826.241

III 111111111110 g 1 Y I IMPLANTING METHOD- BACKGROUND OF THE INVENTIONThe present invention relates to the implanting of devices in the bodiesof living creatures such'as human beings.

As is well known, it is advisable and necessary under certain conditionsto introduce an artificial implant device into the body of a livingcreature such as a human being. Such devices may take many differentforms. For example pacemakers may be implanted to control the operationsof the heart. An artificial heart itself may be implanted. Artificialbones or parts of bones, including artificial teeth, may be implanted.Valves may be implanted to control the flow of body fluids.

One of the major problems encountered when dealing with implants is thatin many cases the body rejects the implant. Although great care may beexercised in the choice of the materials used for the device which is tobe implanted, the number of different materials which are known to becompatible with human tissue is extremely small, and when a compatiblematerial, such as gold, is used, the costs are extremely high.

A further problem encountered in connection with implants is thereliability of the anchoring of the implant of the desired location.After a given device has been implanted it may undesirably move from itsinitial location. Furthermore, where a seal is required between theexterior surface of the implanted device and the tissue of the body, asis the case with valves, for example, such a seal can not always bereliably achieved.

SUMMARY OF THE INVENTIONv It is accordingly a primary object of thepresent invention to provide a method for avoiding the above drawbacks.

In particular, it is an object of the present invention to provide animplanting method which will greatly reduce the possibility of rejectionof the implanted deprovide a method of this type which is easy toperform at a relatively low cost and without any particular danger tothe individual who is to receive the implant.

Yet another object of the present invention is to provide a method whichenables implanting of a device in such a way that not only is thepossibility of rejection greatly reduced but in addition the device willbe reliably anchored at the desired location in a manner which willreliably avoid undesirable movement of the device and leakage of bodyfluids along the exterior of the device.

According to the method of the invention the device which is to beimplanted is initially embedded in tissue of the body which isultimately to receive the device, with this latter tissue being locatedat a part of the body different from the predetermined location whichultimately receives the device. The embedded device is permitted toremain in the tissue in which his initially placed for a length of timesufficient to permit ingrowth of tissue into intimate contact with theexterior surface of the device. Then the device is removed from the bodywhile retaining on the device a layer of the tissue which has grown intocontact with the exterior surface of the device. This device with thelayer of tissuewhich has grown thereon is then implanted in the body atthe predetermined location where tissue of the body is placed directlyin contact with the tissue previously grown onto the device so that itis only required forthe tissue at the ultimate location of the device tobecome united with tissue already grown onto the device in the same bodyin which the device is ultimately implanted, thus reducing thepossibility of rejection.

BRIEF DESCRIPTION OF DRAWINGS first step in FIG. 4 is a schematic.representation of the manner in which a device in the condition shownin FIG. 3 is implanted at its ultimate location in the body.

DESCRIPTION OF PREFERRED EMBODIMENTS Referring to FIG. 1, there isillustrated therein the device 10 which is to be implanted in the bodyof a living creature such as a human being. In the illustrated examplethis device 10 is a valve, but it is to be understood that anyartificial device may be treated according to the present invention,such as pacemakers, artificial organs, artificial bones or partsthereof, teeth, etc.

' FIG. 1 schematically represents a part 12 of the body of a humanbeing, this part 12 being composed of a body of tissue 14 covered withexterior skin l6. The tissue 14 is preferably located at a part of thebody where a relatively large amount of such tissue is readilyaccessible at the exterior skin 16. For example a buttock isparticularly suitable for this purpose.

According to the first step of the method of the invention an incision18 is made through the skin 16 into the tissue 14 so as to form in thetissue 14 a pocket 20 by stretching the tissue and skin 16 at the regionof the incision 18 in the manner shown schematically in FIG. 1. Thepocket 20 is of course made somewhat larger than the device 10 so thatthrough the incision 18 the device 10 can be readily introduced into thepocket 20. Then the incision 18 is closed and sutures may be applied forthis purpose, so that the device 10 remains embedded in the tissue 14 asindicated schematically in FIG. 2. The device 10 can remain in thiscondition shown in FIG. 2 in the body of an individual without creatingany particular problems or any particular discomfort, and during aperiod of time which may be on the order of two or three months, theingrowth of the tissue 14 will take place into intimate contact with theexterior surface of the device 10. For this purpose, an individual maygo to a hospital for no more than overnight stay, so that the surgeoncan embed the device 10 in the tissue 14. Then the individual may leavethe hospital and go about his business in a usual manner for a period oftwo or three months, until ingrowth of tissue has been completed.

In order to promote ingrowth of tissue it is possible to situate at theexterior of the device 10, prior to embedding thereof in the tissue 14,a means 22 which will promote the ingrowth of tissue. In the exampleillustrated in FIG. 1 this means takes the form of one or more strandsof gold wire wound around the valve at the exterior thereof to form alarge number of interstices through which the tissue will grow intointimate contact with the exterior surface of the device 10. Otherstructures may be used to form the means 22 for promoting the ingrowth'of tissue. For example any layer of porous material such as goldsprayed onto the exterior surface of the device 10 in a suitableevacuated atmosphere may be used.

After the period required for completion of ingrowth of tissue haselapsed, the individual returns to the hospital and the surgeon willremove the device 10 from the tissue 14 in which it was initiallyembedded. At this stage of the method of the invention the surgeon iscareful to leave on the device 10 a layer 24 of the tissue which hasgrown into intimate contact with the exterior surface of the device 10.In the particular example shown in the drawings where a valve is usedfor the device 10, an operating component 26 of the valve may be leftexposed so that the valve can be opened and closed. However, whendealing with other types of devices such exposure of part of the devicemay not be required. It is to be noted that in accordance with theinvention any of the artificial devices which are to be implanted haveexterior surfaces which are impervious to tissue so that tissue cannotgrow into the device beyond the exterior surface thereof.

Immediately subsequent to the removal of the device 10 from the tissue14 with the layer 24 of ingrown tissue remaining on the device 10, onlyat the exteriorsurface thereof, the surgeon will introduce the device 10into the part of the body where the device is to remain. Thus, FIG. 4shows by way of example, in a schematic manner, a vas deferens 28initially formed in a wall portion thereof with a slit 30 through whichthe device 10 with the ingrown tissue 24 thereon is introduced in themanner shown in FIG. 4.

With this method the inner tissue 32 which lines the cavity formed bythe interior of the vas 28 directly engages only the ingrown tissue 24from the very same individual in which the device 10 is implanted. It isthus required that the tissue 32 become united only with tissue 24, andsince the tissue 32 and the tissue 24 are from the same individual thepossibility of rejection is very greatly reduced. In addition, theuniting of the tissue 32 with the tissue 24 by ingrowth of the tissue 32into intimate union with the tissue 24 reliably anchors the device 10 atthe desired location and in the case of a valve reliably prevents anyleakage past the valve at the exterior thereof. Of course, in the caseof a valve care is taken to maintain the ends 36 and 38 of the valveopen so that the flow of fluids can readily be controlled by opening andclosing of the valve.

Of course, after the device 10 is removed with the tissue 24 remainingthereon, the second incision which is made is again closed so that thepart 12 of the body where the tissue 14 is located will heal up readily.

It is emphasized that the method of the invention is illustrated abovein connection with a valve only by way of example. The method of theinvention is applicable to all types of devices which are to beimplanted in the body of a living creature such as a human being. Forexample in FIG. 4 the tubes connected to the device may be arteriesconnected to an artificial heart. As was pointed out above pacemakersmay be treated in the manner indicated above so as to be reliablyretained in the body without any possibility of rejection. Furthermorethe method of the invention may be practiced with any artificialmaterials or devices such as a section of artificial bone which is to beintroduced, a tooth which is to be implanted in gums, or even tubes,plates, or the like which are to be used to repair injuries to any bodycavities.

What is claimed is:

1. In a method for implanting in the body of a living creature such as ahuman being an artificial implant device which has an exterior surfacewhich is impervious to the growth of tissue so that tissue cannot growinto the device beyond the exterior surface thereof, the steps ofinitially embedding the device in tissue of the living creature at alocation different from a predetermined location at which the device isultimately to be located and remain, while exposing only the exteriorsurface of the device to the tissue and permitting the device to remainin the tissue in which it is initially embedded until ingrowth of tissueinto intimate contact only with the exterior surface of the device iscompleted, then removing the device from the location at which it wasinitially embedded while retaining only at the exterior of the devicetissue which has grown into contact only with the exterior surface ofthe device, and then surgically obtaining access to said predeterminedlocation and implanting the device with the tissue thereon only at theexterior surface thereof at said predetermined location with the tissueat the exterior of the device engaging tissue located at saidpredetermined location, and then surgically closing off access to saidpredetermined location so that at said predetermined location tissue ofthe body need only become united with tissue of the same body, wherebythe possibility of rejection of the device is reduced.

2. A method as recited in claim 1 and including the step ofpreliminarily locating at the exterior surface of the device, prior toinitial embedding thereof, a means which will permit the ingrowth oftissue.

3. A method as recited in claim 1 and wherein the tissue is initiallyembedded at a part of the body where a relatively large volume of tissueis readily accessible from the exterior of the body.

4. A method as recited in claim 3 and wherein the part of the body wherethe device is initially embedded is a buttock.

5. A method as recited in claim 1 and wherein said predeterminedlocation is the interior of a body cavity which is lined with tissueplaced in engagement with the tissue preliminarily grown onto the deviceand retained thereon when the device is removed from the location atwhich it is initially embedded.

6. A method as recited in claim 5 and wherein the cavity is the interiorof a vas deferens of human male and the device is a valve.

7. A method as recited in claim 6 and wherein wire is preliminarilywound onto the exterior of the valve prior to initial embedding thereoffor promoting ingrowth of tissue.

8. A method as recited in claim 1 and wherein the device is a valve.

9. A method as recited in claim 1 and wherein the device is implanted atsaid predetermined location immediately subsequent to removal of thedevice from the location at which it was initially embedded.

* x: a a m

1. In a method for implanting in the body of a living creature such as ahuman being an artificial implant device which has an exterior surfacewhich is impervious to the growth of tissue so that tissue cannot growinto the device beyond the exterior surface thereof, the steps ofinitially embedding the device in tissue of the living creature at alocation different from a predetermined location at which the device isultimately to be located and remain, while exposing only the exteriorsurface of the device to the tissue and permitting the device to remainin the tissue in which it is initially embedded until ingrowth of tissueinto intimate contact only with the exterior surface of the device iscompleted, then removing the device from the location at which it wasinitially embedded while retaining only at the exterior of the devicetissue which has grown into contact only with the exterior surface ofthe device, and then surgically obtaining access to said predeterminedlocation and implanting the device with the tissue thereon only at theexterior surface thereof at said predetermined location with the tissueat the exterior of the device engaging tissue located at saidpredetermined location, and then surgically closing off access to saidpredetermined location so that at said predetermined location tissue ofthe body need only become united with tissue of the same body, wherebythe possibility of rejection of the device is reduced.
 2. A method asrecited in claim 1 and including the step of preliminarily locating atthe exterior surface of the device, prior to initial embedding thereof,a means which will permit the ingrowth of tissue.
 3. A method as recitedin claim 1 and wherein the tissue is initially embedded at a part of thebody where a relatively large volume of tissue is readily accessiblefrom the exterior of the body.
 4. A method as recited in claim 3 andwherein the part of the body where the device is initially embedded is abuttock.
 5. A method as recited in claim 1 and wherein saidpredetermined location is the interior of a body cavity which is linedwith tissue placed in engagement with the tissue preliminarily grownonto the device and retained thereon when the device is removed from thelocation at which it is initially embedded.
 6. A method as recited inclaim 5 and wherein the cavity is the interior of a vas deferens ofhuman male and the device is a valve.
 7. A method as recited in claim 6and wherein wire is preliminarily wound onto the exterior of the valveprior to initial embedding thereof for promoting ingrowth of tissue. 8.A method as recited in claim 1 and wherein the device is a valve.
 9. Amethod as recited in claim 1 and wherein the device is implanted at saidpredetermined location immediately subsequent to removal of the devicefrom the location at which it was initially embedded.